Urinary catheter or plug and method for managing urinary incontinence

ABSTRACT

The disclosure provides a device and method for managing urinary incontinence. The device includes a platform, a balloon, and a valve. The platform and balloon can include a silicone material, a thermoplastic material, and an adhesive and/or a cement for sealing the urethra. The thermoplastic and silicone materials can soften at the body temperature so that their shape can be adapted to fit the three-dimensional contour of surfaces of the urethra. The balloon seals the internal orifice of the urethra, and the platform can block the leakage associated with the balloon. The valve permits selective urine voiding. The method includes inserting the device into the urethra and the bladder. The method can also include inflating the balloon. The method can further include pulling the balloon so that the balloon is in sealing contact with the neck of the bladder and moving the platform to a suitable position for sealing the urethra.

FIELD

The disclosure relates to a device and a method for managing urinaryincontinence. Specifically, the disclosure relates to a urinary catheteror plug for voiding urine controllably while preventing urine leakageand reducing urinary tract infections.

BACKGROUND

The bladder stores urine. During urination, bladder muscles squeeze thebladder, forcing urine out of the bladder through a passage called theurethra. Sphincter muscles around the urethra function as a valve. Whenthe sphincter muscles relax, the urethra is open, and urine can flow outof the bladder. When the sphincter muscles contract, the urethra isclosed, and urine cannot flow out of the bladder.

Urinary incontinence is the involuntary leakage of urine. Urinaryincontinence can happen when the bladder muscles suddenly contract, andthe sphincter muscles are not strong enough to maintain the close of theurethra. Urinary incontinence may also occur if there is a problem withthe nerves that control the bladder and urethra.

Urinary incontinence is a common and often embarrassing problemaffecting women and men of all ages. Urinary incontinence is more commonamong women than men. Types of urinary incontinence can include stressincontinence, urge incontinence, overflow incontinence, functionalincontinence, and mixed incontinence.

SUMMARY

Embodiments herein provide a device and a method for managing urinaryincontinence. In an embodiment, the device comprises one or morematerials selected from the group consisting of a silicone material, athermoplastic material, an adhesive, and a cement. In an embodiment, thesilicone and thermoplastic materials are capable of softening at thebody temperature of the urethra to be adapted to a shape fitting acontour of an inner surface of the urethra. In an embodiment, theadhesive or cement can hold or bond the device and a urethral mucousmembrane or orifice together and sealing gaps therebetween.

In an embodiment, the thermoplastic material is a thermoplasticelastomer that includes at least one selected from the group consistingof styrenic block copolymers, thermoplastic olefin blends (TPO),thermoplastic polyurethanes (TPU), elastomeric alloys (TPV),thermoplastic copolyester (COPE), and polyether block amides (PEBAX),and the like and combinations thereof.

In an embodiment, the adhesive or cement is selected from the groupconsisting of a silicone adhesive or cement, a hydrocolloid adhesive orcement, and an acrylic adhesive or cement, and the like and combinationsor composites thereof.

In an embodiment, the silicone and thermoplastic materials have ahardness in a range of at or about 0 to at or about 80 on the Shore 00scale of hardness at the body temperature of the urethra. In anembodiment, the silicone and thermoplastic materials have a hardness ina range of at or about 10 to at or about 40 on the Shore 00 scale ofhardness at the body temperature of the urethra. In an embodiment, thesilicone and thermoplastic materials have a hardness in a range of at orabout 40 to at or about 65 on the Shore 00 scale of hardness at the bodytemperature of the urethra.

In an embodiment, the device further comprises an inner body. In anembodiment, the inner body is made of the silicone material, thethermoplastic material, or a combination thereof. In an embodiment, theinner body is made of a silicone rubber. In an embodiment, thethermoplastic elastomer is provided around the inner body.

In an embodiment, the inner body is an elongated body insertable into aurethra through an external opening of the urethra.

In an embodiment, a platform is disposed around the elongated body andmovable axially along the elongated body so that the platform isretained at different positions of the elongated body. The platform iscapable of sealing the urethra and blocking microbe entry. In anembodiment, the platform is made of silicone material, thermoplasticmaterial, or a combination thereof. In an embodiment, the platform ismade of a silicone rubber.

In an embodiment, the adhesive or cement is provided on a surface of theplatform. In an embodiment, the platform includes a first adheringsurface containing a first adhesive or cement capable of holding orbonding the device and the urethral mucous membrane or orifice togetherand sealing gaps therebetween in a releasable and reusable manner. In anembodiment, the platform includes a second adhering surface containing asecond adhesive or cement capable of adhering the platform to theelongated body.

In an embodiment, the device further comprises an inflatable ballooncapable of sealing the internal orifice of the urethra. In anembodiment, the inflatable balloon includes the silicone material, thethermoplastic material, a combination thereof, which is capable ofsoftening at the body temperature of the bladder. In an embodiment, thethermoplastic material is a thermoplastic elastomer. In an embodiment,the inflatable balloon includes an adhesive capable of holding theballoon and the membrane of the neck of the bladder in a releasable andreusable manner and sealing gaps therebetween.

In an embodiment, the elongated body comprises a proximal portion and adistal portion, and the proximal portion is firmer than the distalportion. In an embodiment, the proximal portion has a hardness in arange of 40 to 100 on the Shore A scale of hardness at body temperature.In an embodiment, the distal portion has a hardness in a range of 0 to40 on Shore A scale of hardness.

In an embodiment, the device further comprises a valve for control ofurinary voiding. In an embodiment, the valve comprises a battery, acoil, a spring, a plunger, and a leaf. In an embodiment, the coilgenerates an electromagnetic field when electric current flows throughthe coil, which causes the spring to contract and, in turn, causes theplunger to retract so that the leaf is open to allow urine to flowthrough the valve. In an embodiment, when the electric current stopsflowing through the coil, the coil no longer generates anelectromagnetic field, and the spring expands, which in turn causes theplunger to be pushed back so that the leaf is in a closed state to stopurine flowing through the valve.

In an embodiment, the method comprises inserting the device through theexternal orifice of the urethra, wherein the platform contacts and sealthe external urethral orifice. In an embodiment, inserting the deviceincludes inserting the inflatable balloon inside a bladder. In anembodiment, the method further comprises inflating the inflatableballoon. In an embodiment, the method further comprises pulling theballoon so that the balloon is in sealing contact with the neck of thebladder and/or the internal urethral orifice. In an embodiment, themethod further comprises adjusting the platform position to seal theexternal urethral orifice while the balloon seals the internal urethralorifice.

BRIEF DESCRIPTION OF THE DRAWINGS

References are made to the accompanying drawings that form a part ofthis disclosure, and which illustrate embodiments in which the devicesand methods described in this specification can be practiced.

FIG. 1 schematically illustrates a urinary catheter, according to anembodiment.

FIG. 2 schematically illustrates a urethral plug, according to anembodiment.

FIG. 3 schematically illustrates a top view of a urethral plug,according to another embodiment.

FIG. 4 schematically illustrates a urinary catheter, according toanother embodiment.

FIG. 5A schematically illustrates a valve in a closed state from a sideview, according to an embodiment.

FIG. 5B schematically illustrates a valve in a closed state from a topview along the urine flow F, according to an embodiment.

FIG. 5C schematically illustrates a valve in an open state from a sideview, according to an embodiment.

FIG. 5D schematically illustrates a valve in an open state from a topview along the urine flow F, according to an embodiment.

FIG. 6 schematically illustrates the use of a sensor and a portable orwearable device to control on and off of the valve, according to anembodiment.

FIG. 7A schematically shows a side view of a platform, according to anembodiment.

FIG. 7B schematically shows a tilt view of the platform of FIG. 7A,according to an embodiment.

FIG. 7C schematically shows an exploded view of the platform of FIG. 7A,according to an embodiment

Like reference numbers represent like parts throughout.

DETAILED DESCRIPTION

The term “a,” “an,” or “the” cover both the singular and the pluralreference, unless the context clearly dictates otherwise. The terms“comprising,” “having,” “including,” and “containing” are open-endedterms, which means “including but not limited to,” unless otherwiseindicated.

Certain values herein are preceded by the term “about.” The term “about”herein provides literal support for the exact value that it precedes, aswell as a range that is near to or approximately the value that the termprecedes. In an embodiment, the range is from 70% to 130% of the exactvalue that the term “about” precedes. In an embodiment, the range isfrom 80% to 120% of the exact value that the term “about” precedes. Inan embodiment, the range is from 90% to 110% of the exact value that theterm “about” precedes. In an embodiment, the range is from 99% to 101%of the exact value that the term “about” precedes. For example, if theexact value is 100, the range from 70% to 130% of the exact value is 70to 130.

The disclosure relates to a device and method for managing urinaryincontinence. Specifically, the disclosure relates to a urinary catheteror plug for preventing urine leakage and reducing urinary tractinfections. The device can be a urinary catheter or plug. The device hasthe advantage of preventing intraurethral leakage and bladderinfections.

Referring to FIG. 1 , FIG. 1 illustrates a urinary catheter 100 formanaging urinary incontinence, according to an embodiment. The urinarycatheter 100 can be formed from any suitable non-allergenic, softmaterial that does not irritate and damage the urethra and bladdertissues but generally firm enough to be inserted into the urethra andbladder. The urinary catheter 100 can address many drawbacks of atraditional Foley type catheter, particularly its relatively highintraurethral leakage rate. The urinary catheter 100 can comprise anelongated body 101 and a platform 120. The platform 120 can act as aplug of the urethra, preventing urine from leaking out of the urethra,blocking bacteria or other microbes from migrating into the bladder, andreducing urinary tract infections (UTI). The platform 120 is provided toseal the urethra so that the urine exits the bladder through the urinepassage 105. In an embodiment, when the urinary catheter 100 is in usefor managing urinary incontinence, the platform 120 resides at theexternal urethral orifice. In an embodiment, the platform 120 resides atthe distal end of the urethra for sealing the exterior orifice of theurethra. In an embodiment, the platform 120 resides within the urethrafor sealing the urethra.

The platform 120 can be made from a silicone material, a thermoplasticmaterial, an adhesive, a cement, a thermo-impression material, or anyother suitable non-tissue irritating, non-allergenic material, or acombination thereof. In an embodiment, the suitable non-tissueirritating, non-allergenic material enables the platform 120 to form animpression of the opposing mucosa membrane and/or urethral orifice toobtain a seal or adherence sufficient to prevent urine leakage andbacterial migration into the bladder. In an embodiment, the suitablenon-tissue irritating, non-allergenic material is a material that isfirm enough to hold the adhesive, cement, and/or thermoplastic materialbut soft enough not to irritate the involved tissue. Thethermos-impression material can include one or more material selectedfrom the group consisting of a polysiloxane thermo-impression materialand a polyether thermo-impression material.

In an embodiment, the platform 120 is made of a silicone material or amaterial containing silicone. In an embodiment, the platform 120 is madeof medical-grade silicone. In an embodiment, the platform 120 is made ofa silicone rubber. In an embodiment, the platform 120 comprises asilicone rubber. In an embodiment, the platform 120 is coated with asilicone material. In an embodiment, the silicone rubber is a liquidsilicone rubber. In an embodiment, the platform 120 can be latex-free.

In an embodiment, the platform 120 is made of a thermoplastic material.In an embodiment, the thermoplastic material is a thermoplasticelastomer. In an embodiment, the platform 120 is constructed from athermoplastic material. In an embodiment, the platform 120 comprises athermoplastic material. In an embodiment, the platform 120 includes athermoplastic material provided on its outer surface. Suitablethermoplastic material includes but is not limited to, for example,styrenic block copolymers (for example, styrene butadiene styrene (SBS),styrene ethylene butylene styrene (SEBS)), thermoplastic olefin blends(TPO), thermoplastic polyurethanes (TPU), elastomeric alloys (TPV),thermoplastic copolyester (COPE), and polyether block amides (PEBAX),and the like and combinations thereof. In an embodiment, thethermoplastic material is capable of holding the platform 120 and theurethral mucous membrane or orifice together without irritating ordamaging a tissue thereof.

In an embodiment, the silicone and thermoplastic materials can have asoftness (hardness) in a range of at or about 10 to at or about 40 onthe Shore 00 scale of hardness at a body temperature. In an embodiment,the silicone and thermoplastic materials can have a softness (hardness)in a range of at or about 40 to at or about 65 on the Shore 00 scale ofhardness at a body temperature. In an embodiment, the body temperatureis the temperature within the urethra. In an embodiment, the bodytemperate is the temperature within the bladder. In an embodiment, thebody temperature is at or about 36.5° C. to at or about 37.5° C. In anembodiment, the body temperature is at or about 37.06° C.

In an embodiment, the silicone and thermoplastic materials can soften ata body temperature to form the impression of the opposing mucosa andurethral orifice to obtain the seal or adherence sufficient to preventurine leakage and bacterial migration into the bladder. That is, whenthe silicone or thermoplastic material is within the urethra, thesilicone or thermoplastic material softens and becomes deformable sothat the platform 120 can adjust its shape to mate the three-dimensionalcontour of the inner surface or orifices of the urethra, resulting in anexcellent sealing effect. The platform 120 is impermeable to body fluidand urine from the bladder.

In an embodiment, the softness, pliability, and/or elasticity of theplatform 120 can be further adjusted by forming cavities or channelswithin the platform 120. In an embodiment, the softness, pliability,and/or elasticity of the platform 120 can be further adjusted by formingcavities within the silicone and/or thermoplastic material.

The platform 120 can also be formed from a non-allergenic andnon-irritating medical material other than or in addition to thesilicone and/or the thermoplastic material. In an embodiment, theplatform 120 includes a soft, foamed material, which can provide a softdeformable outer surface to fit the inner contour of the urethra.

The platform 120 may or may not contain one or more adhesive or cementon its surface(s). In an embodiment, the platform 120 includes anadhesive or cement. The adhesive or cement can be biocompatible withoutirritating or damaging the involved tissue. The adhesive or cement canalso be releasable and reusable. That is, the adhesive or cement isdetachable from an adherence surface and re-adherable to a new surface.In an embodiment, the adhesive is a substance or composition that holdsthings together. In an embodiment, the adhesive is used so that apatient can pull off the platform 120 and re-adhere the platform 120 byforce. In an embodiment, the cement is a chemical compound orcomposition that bonds two surfaces. In an embodiment, the cement isused so that a patient can use a chemical reaction to attach and/ordetach the platform 120, for example, by applying a chemical. Theadhesion or bonding can resist the stress and pressure due to the urinein the bladder.

In an embodiment, the platform 120 includes a first adhesive surfacecontaining a first adhesive or cement for adhering the platform 120 tothe urethral mucous membrane or orifice and sealing the gapstherebetween.

In an embodiment, the platform 120 includes a second adhesive surfaceincluding a second adhesive or cement for adhering the platform 120 tothe elongated body 101.

In an embodiment, the first and/or second adhesive surface furtherincludes a thermoplastic material such as, for example, a thermoplasticelastomer to give the adhesion between the platform 120 and the involvedtissue more strength and plasticity. In an embodiment, the first and/orsecond adhesive surface also includes a silicone material to improve theadhesion strength and plasticity. In an embodiment, the first and/orsecond adhesion surface does not contain a thermoplastic material and/ora silicone material.

The adhesive or cement, including the first and second adhesive orcement, can generally be any suitable adhesive or cement capable ofadhering the platform 120 to the urethral mucous membrane and orificewithout irritating or damaging involved tissues. The adhesive or cementcan be one or more materials selected from a group, including but notbeing limited to silicone adhesives, hydrocolloid adhesives, acrylicadhesives, elastomeric adhesives, thermoplastic adhesives, acrylicadhesives, emulsion adhesives, and thermoset adhesives, and the like,and/or combinations or composites thereof. The adhesive or cement canalso be produced by or obtained from a living organism. In anembodiment, the adhesive or cement is a silicone adhesive or cement. Inan embodiment, the adhesive or cement is a hydrocolloid adhesive orcement. In an embodiment, the adhesive or cement is an acrylic adhesiveor cement.

The platform 120 can be soft, smooth in texture to avoid damage to thesurrounding tissue while inserting or pulling the urinary catheter 100.In an embodiment, the platform 120 can have a softness (hardness) in arange of at or about 0 to at or about 80 on the Shore 00 scale ofhardness at a body temperature. In an embodiment, the upper limit of therange of the hardness can be at or about 75, at or about 70, at or about65, at or about 60, at or about 55, at or about 50, at or about 45, orat or about 40. In an embodiment, the lower limit of the range of thehardness can be at or about 5, at or about 10, at or about 15, at orabout 20, at or about 25, at or about 30, at or about 35, at or about40, at or about 45, at or about 50, at or about 55, or at or about 60.

The elongated body 101 includes a top end 102 and a bottom end 107,viewed from the orientation shown in FIG. 1 . The elongated body 101 canbe made from a thermoplastic material or silicone material. In anembodiment, the elongated body 101 is made from a thermoplasticelastomer. In an embodiment, the elongated body 101 is made from asilicone rubber.

In an embodiment, the urinary catheter 100 also includes, from the topend 102 to the bottom end 107, a balloon 110, an inflation tube 114, andan inlet 112 for balloon inflation or deflation. In an embodiment, theurinary catheter 100 further includes a plurality of openings 103, aurine passage 105, and/or a urination controller 140.

The urine passage 105 communicates with the openings 103. In anembodiment, the openings can be Murphy eye openings or any suitableopening to allow urine to pass into the elongated body 101. In anembodiment, the elongated body 101 defines an inner lumen that forms theurine passage 105. In an embodiment, the urine passage 105 extends fromthe top end 102 to the bottom end 107.

When the urinary catheter 100 is in place for managing urinaryincontinence, the top end 102, the openings 103, and the balloon 110 arewithin the bladder. Urine in the bladder can flow into the urine passage105 through the openings 103 and then exit from the urine passage 105through the bottom end 107. The top end 102 can be a closed or partiallyclosed end. The top end 102 can have any suitable shape. In anembodiment, the top end 102 has a round shape. The bottom end 107 caninclude a discharge opening 108 where urine exits the urinary catheter100.

The balloon 110 is inflatable. When the balloon 110 is inflated, theballoon 110 can seal the internal orifice of the urethra so that urineexits the bladder through the urine passage 105 of the urinary catheter100, not the urethra. The balloon 110 is in fluid communication with theinlet 112 through the inflation tube 114. The inflation tube 114 definesan inflation lumen 115, through which air or liquid can flow into or outof the balloon 110. In an embodiment, the air or liquid can be injectedthrough the inlet 112 and the inflation lumen 115 to inflate theinterior region of the balloon 110. In an embodiment, the inlet 112 isprovided with an adapter 113 fitted to a Luer lock or Luer slip of asyringe so that a normal medical syringe can inflate the balloon 110. Inan embodiment, the inflation tube 114 is provided with a release device117 for discharging fluid out of the inflated balloon 110. In anembodiment, the release device 117 enables a rapid release of the fluidfrom the balloon 110 into the inflation tube 114 and out of the urinarycatheter 100. In an embodiment, the release device 117 is a valve. In anembodiment, the release device 117 is a palpitatable valve. As the fluidis released from the balloon 110, the balloon 110 deflates, and theurinary catheter 100 can be safely removed without causing urethralinjury. In an embodiment, the fluid is air. In an embodiment, the fluidis water. In an embody, the fluid is an antimicrobial solution. In anembodiment, the fluid is a saline solution.

The device can be removed by deflating the inflated balloon 110 locatedin the bladder and then gently pulling on the urinary catheter 100,which will release the platform 120.

The balloon 110 can be made from any suitable material. In anembodiment, the balloon 110 is made from a thermoplastic material. In anembodiment, the balloon 110 is made from an elastomer. In an embodiment,the balloon 110 includes a thermoplastic elastomer on its exteriorsurface. In an embodiment, the balloon 110 is coated with a siliconerubber.

In an embodiment, the platform 120 holds the balloon 110 in a sealingcontact with the neck of the bladder. In an embodiment, the balloon 110includes an adhesion surface provided on a surface 111 where the balloon110 contacts the neck and/or the internal orifice of the urethra whenthe balloon 110 is in place for managing urinary incontinence. In anembodiment, the adhesion surface adheres the balloon 110 to the neck andsealing gaps therebetween in a releasable and reusable manner. In anembodiment, the adhesion surface includes an adhesive discussed above.

The distance between the platform 120 and the balloon 110 can beconfigurable to fit different patients. In an embodiment, a retainer 125is provided between the platform 120 and the elongated body 101 foradjusting the position of the platform 120. The platform 120 can bemovable axially along the retainer 125. In an embodiment, the retainer125 includes ridges, and the platform 120 can slide axially along theridges. In an embodiment, the retainer 125 may be threaded, and theplatform 120 can move up or down along the thread by rotation. Theretainer 125 can retain the platform 120 at different positions of theelongated body 101 so that the urinary catheter 100 can fit differentlengths of the urethra.

In an embodiment, the retainer 125 is molded onto the elongated body101. The retainer 125 can be firm so that it can retain the platform120. In an embodiment, the retainer 125 is fixed on the elongated body101 by an adhesive or cement or the like. In an embodiment, the retainer125 and the elongated body are unitary one piece and constructed fromthe same material.

The platform 120 can also be preconfigured to have various distancesfrom the balloon 110 to fit various lengths of patients' urethra. In anembodiment, the urinary catheter 100 can be manufactured with differentdistances between the platform 120 and the balloon 110 to fit variouspatients' needs. In an embodiment, the urinary catheter 100 does notinclude the retainer 125, in an embodiment, the platform 120 is directlymolded on the elongated body 101. In an embodiment, the platform 120 isdirectly fixed on the elongated body 101 with an adhesive or cement orthe like.

The urinary catheter 100 can be inserted into the urethra and thebladder. After the balloon 110 is inflated through the inlet 112, theurinary catheter 100 is gently pulled so that the balloon 110 can be infirm contact with the neck of the bladder to seal the internal orificeof the urethra. The platform 120 is also advanced along with the urinarycatheter 100 to reach a suitable position on the urethral orifice. In anembodiment, the platform 120 is advanced until its adhesion surfacecontacts the external orifice of the urethra. The platform 120 thensoftens at body temperature, forming a waterproof seal with the externalurethral orifice.

Compared to the traditional Foley type catheter, the platform 120 canprevent urine leakage and reduce bacterial infections due to using aninflatable balloon alone for sealing, as the inflatable balloon of thetraditional Foley type catheter has drawbacks in allowing intraurethralleakage. Combining the platform 120 with the balloon 110 can ensureurine exits the bladder only through the urine passage 105 of theurinary catheter 100, not the urethra. The platform 120 and the balloon110 provide the urinary catheter 100 with advantages over thetraditional Foley type catheter, as it can minimize or prevent the urineleakage associated with the traditional Foley type catheter. Althoughthe traditional Foley type catheter may include a structure calledcollar, the collar is typically disposed outside of the urethra and notin contact with the distal end of the urethra. Thus, the collar isprimary for stabilizing the inflatable balloon, not for sealing.

The elongated body 101 can be divided into two portions: a proximalportion 160 and a distal portion 180. The proximal portion 160 can begenerally disposed within the urethra and bladder. In an embodiment, thedistal portion 180 is absent. In an embodiment, the proximal portion 160is firm and polished. The firmness of the proximal portion 160 enablesthe insertion of the urinary catheter 100 into the urethra and bladder.In an embodiment, the proximal portion 160 can have a hardness in arange of at or about 40 to at or about 100 on the Shore A scale ofhardness at the body temperature. In an embodiment, the proximal portion160 can also be slightly elastic to provide a comfortable wearingexperience. The distal portion 180 can be disposed outside the urethraand bladder. The distal portion 180 can be short in length so that it ishidden and does not interfere with the mobility of a user. In anembodiment, the distal portion 180 is soft and pliable. The softness andpliability of the distal portion 180 enables the urinary catheter 100 tobe worn without interfering with the normal activities of the user andwithout being evident. In an embodiment, the distal portion 180 can havea hardness in a range of at or about 0 to at or about 40 on Shore Ascale of hardness at the body temperature.

In an embodiment, the proximal portion 160 and the distal portion 180are a unitary one-piece construction. In an embodiment, the proximalportion 160 and the distal portion 180 are made from different materialsand molded together.

It is appreciated that the distal portion 180 can have the same firmnessas that of the proximal portion 160. In an embodiment, the proximalportion 160 and the distal portion 180 have a hardness in a range of ator about 50 to at or about 100 on the Shore A hardness scale at the bodytemperature. In an embodiment, the proximal portion 160 and the distalportion 180 are unitary one-piece constructed from the same material.

The urination controller 140 can open or close the urine passage 105,permitting selective voiding. When the urine passage 105 is open, urinecan be discharged from the bladder. When the urine passage 105 isclosed, urine is retained in the bladder.

The urination controller 140 can be or include a plug or valve. When apatient wants to or feels the need to void, he/she can displace the plugor open the valve. After the patient has voided, he/she can replace theplug or close the valve. In an embodiment, the urination controller 140is a plug that can closely fit and seal the discharge opening 108 of theelongated body 101. In an embodiment, the plug can be plugged into thedischarge opening 108 and retained to close the urine passage 105.

In an embodiment, the urination controller 140 can be or include adischarge valve. In an embodiment, the valve is a mechanical valve,including but not being limited to, for example, ball-and-seat valve,duckbill valve, inflatable check valve, dome-type valve, or the like, orany suitable valve. The valve can be operated manually or electronicallyby the user or patient. In an embodiment, the valve can be apalpitatable discharge valve as a portion of the valve can be squeezedor pressed to open the valve. The palpitatable discharge valve can beorientation-dependent (uniaxial) or orientation independent(multi-axial), based upon whether pressure needs to be applied to a pairof selected points or surfaces in order to open the valve sufficientlyfor normal discharge operation, or whether the valve will open whenpressure is exerted radially from any two opposing directions. In anembodiment, the discharge valve is a uniaxial duckbill valve, which canbe rotated between the user's fingers until pressure is directed on theproper sites to maximize fluid flow. In an embodiment, the dischargevalve is a palpitatable multi axial dome-type discharge valve.

In an embodiment, the urination controller 140 and the elongated body101 are separate pieces assembled together. In an embodiment, theurination controller 140 is attached to the elongated body 101 by anadhesive or cement. In an embodiment, the urination controller 140 andthe elongated body 101 are not separate pieces. In an embodiment, theurination controller 140 is molded onto the elongated body 101. In anembodiment, the urination controller 140 includes or is a plug, and theplug and the elongated body 101 is a unitary one-piece construction.

In an embodiment, the exteriors of the distal portion 160, the urinationcontroller 140, the inlet 112 comprises a silicone rubber, which canprovide an excellent wearing experience. In an embodiment, the siliconerubber is medical latex-free silicone rubber.

It is appreciated that some features discussed above can be optional. Inan embodiment, the urinary catheter 100 does not include the inflatableballoon 110. In an embodiment, the urinary catheter 100 does not includethe openings 103. In an embodiment, the urinary catheter 100 does notinclude the openings 103, the inflatable balloon 110, the inlet 112, andthe inflation tube 114.

Referring to FIG. 2 , FIG. 2 illustrates a urethral plug 200, accordingto an embodiment. The urethral plug 200 can be inserted into or onto theurethra to block urine from flowing through the urethra. In anembodiment, the urethral plug 200 can include an elongated body 201 anda platform 220.

The elongated body 201 is soft but firm enough to enable the urethraplug 200 to be inserted into the urethra. The material and softness ofthe elongated body 201 are similar to those discussed above for theproximal portion 160 of the elongated body 101. The features discussedabove for the proximal portion 160 of the elongated body 101 isincorporated herewith.

The platform 220 seals the urethra and can be functionally similar tothe platform 120 in FIG. 1 . The features discussed above for theplatform 120 are applicable to the platform 220 and incorporateherewith, unless indicated otherwise. In an embodiment, the platform 220contacts and seals the external orifice of the urethra. The platform 220can have material, softness, and structures such as adhesive surfacesimilar to those discussed above for the platform 210.

In an embodiment, a retainer similar to the retainer 125 can also beprovided on the elongated body 201 so that the platform 220 can move orslide axially so that the platform 220 can be inserted into differentpositions of the urethra.

In an embodiment, the elongated body 201 further includes an attachment203. The attachment 203 can be used to unplug the urethral plug 200 whena patient wants to void or feel the need to void. In an embodiment, theattachment 203 can also facilitate placing the urethral plug 200 intothe urethra after the patient voids. In an embodiment, the attachment203 is a ring. In an embodiment, the attachment is a handle. Theattachment 203 is soft and pliable so that it can be worn comfortablywithout being evident and interfering with the normal activity of thepatient. In an embodiment, the material and softness of the attachment203 are similar to those discussed above for the distal portion 180 ofthe elongated body 101. In an embodiment, the attachment 203 is madefrom silicone rubber or liquid silicone rubber.

Referring to FIG. 3 , FIG. 3 illustrates a top view of urethral plug300, according to an embodiment. The urethral plug 300 can be insertedinto or onto the external orifice of the urethra, blocking the urethra.The urethral plug 300 comprises a body 320. The body 320 is functionallysimilar to the platform 120 or 220 discussed above. The body 320 can bemade from similar materials discussed above for the platform 120. Thus,the above discussion of the platform 120 or 220 is incorporatedherewith. In an embodiment, the urethral plug 300 is composed of thebody 320. In an embodiment, the urethra plug 300 further includes aninner body 340. In an embodiment, the body 320 is disposed around theinner body 340. In an embodiment, the inner body 340 is an inner core ofthe urethral plug 300, and the body 320 constitutes an outermost layerof the urethra plug 300. The inner body 340 can be firm to enableinsertion of the urethral plug 300 into the urethra. The inner body 340can be formed from any suitable materials. In an embodiment, the innerbody 340 is formed from a thermoplastic polymer, a silicone material, ora combination thereof. In an embodiment, the thermoplastic polymer is athermoplastic elastomer. In an embodiment, the silicone material issilicone rubber.

When a user inserts the urethral plug 300 onto or into the urethra, thebody 320 contacts the urethral external orifice and/or the mucousmembrane and seals gaps therebetween. Like the urethral plug 200, theurethral plug 300 can include an adhesive surface containing an adhesiveor cement for holding the body 320 and the urethral external orificeand/or mucous membrane together and sealing gaps therebetween. In anembodiment, the body 320 is soft and can form an impression of theopposing urethral orifice and/or mucous membrane to achieve an excellentseal.

Like the urethral plug 200, the urethral plug 300 is removable wheneverthe patient wants to void. The adhesion of the adhesive or cement can bereleasable and/or reusable. In an embodiment, the adhesive or cement canhave a tailorable adhesion time. In an embodiment, the adhesion time isvariable depending on the user's hydration and fluid intake.

Referring to FIG. 4 , FIG. 4 schematically illustrates a urinarycatheter 400, according to another embodiment. The urinary catheter 400can be structurally similar to the urinary catheter 100. Like theurinary catheter 100, the urinary catheter 400 also includes structuralelements such as, for example, the urine passage 105, balloon 110,inflation tube 114, inflation lumen 115, platform 120, urinationcontroller 140, etc. For simplicity of this specification, similar oridentical features to those discussed above are not described in furtherdetail.

Compared to the urinary catheter 100, the urinary catheter 400 may notinclude a retainer disposed between the platform 120 and the elongationbody 101. In an embodiment, the platform 120 directly contacts theelongation body 101. In an embodiment, the platform 120 is movable alongthe elongation body 101. In an embodiment, a user can apply, spray, orpaint an adhesive or cement onto the platform 120 or the elongation body101 and then adjust the platform to a suitable position. When theadhesive or cement takes effect, the platform 120 is adhered to theelongation body 101. In an embodiment, the user applies, sprays, orpaints an adhesive or cement onto the platform 120 to adhere theplatform 120 to the elongated body 101 after adjusting the platform 120to a suitable position. In an embodiment, the adhesive and/or cement ispre-coated onto a suitable surface of the platform 120 and protected bya release cover 422, for example a liner, when the urinary catheter 100is manufactured. The user can peel off the cover 422 to expose theadhesive or cement to adhere the platform 120 to the elongation body 101before or after adjusting the position of platform 120. As discussedabove, the adhesive or cement can be any suitable non-allergenic,non-irritating, biocompatible medical adhesive or cement that canprovide sufficient adherence to resist the urine pressure and bodymovement. In an embodiment, the adhesive or cement is a siliconeadhesive or cement. In an embodiment, the adhesive or cement is anon-silicone adhesive or cement. In an embodiment, the adhesive orcement can be selected from the group consisting of a silicone adhesiveor cement, a hydrocolloid adhesive or cement, an acrylic adhesive orcement, and a combination or composite thereof.

In an embodiment, the platform 120 is directly and removably glued tothe elongation body 101 by, for example, a releasable and reusableadhesive. The releasable and reusable adhesive allows the platform 120to be moved to a new position at the elongation body 101 by pushing orpulling the platform 120 and then adhered to the new position. In anembodiment, the adhesive is pre-coated onto a surface of the platform120 when the urinary catheter 400 is manufactured. In an embodiment, theadhesive can be applied onto the surface of the platform when urinarycatheter 400 is in use. The releasable and reusable adhesive allowsdifferent users to freely adjust and retain the platform 120 to suitablepositions at the elongation body 101, providing a comfortable wearingexperience.

When the adhesive or cement contacts the elongation body 101, theadhesive or cement can provide sufficient adhesion force to retain theplatform 120 and resist the body movement. In an embodiment, theadhesive or cement is coated onto a platform 120's surface that contactsor faces an outer surface of the elongation body 101. In an embodiment,the platform 120's surface directly contacts the elongation body 101.

The platform 120 can further include an adhesive surface 421. Theadhesive surface 421 can be an exterior surface that is not directlycontacted with the elongation body 101. The adhesive surface 421 notonly can adhere the platform 420 to the urethral mucous membrane ororifice but also seal the gaps therebetween.

The adhesive surface 421 contains an adhesive or cement generallydiscussed above concerning the urinary catheter 100. The adhesive orcement may be the same as or different from the above-discussed adhesiveor cement for adhering the platform 120 to the elongation body 101. Inan embodiment, the adhesive or cement on the adhesive surface 421 isdifferent from the one for adhering the platform 120 to the elongationbody 101. In an embodiment, the adhesive or cement on the adhesivesurface 421 is identical or substantially similar to the one adheringthe platform 120 to the elongation body 101.

In an embodiment, the adhesive or cement is coated onto the adhesivesurface 421 when the urinary catheter 400 is manufactured. In anembodiment, the adhesive surface 421 is covered by a cover 423 such as,for example, a release liner. A user can take or peel off the cover 423to expose the adhesive surface 421 before or when the urinary catheter400 is in use. In an embodiment, the adhesive or cement is applied ontothe adhesive surface 421 when the urinary catheter 400 is in use.

In an embodiment, the adhesive or cement on the adhesive surface 421 canhave a tailorable adhesion time. In an embodiment, the adhesion time isvariable depending on the patient's hydration and fluid intake. In anembodiment, the adherence via the adhesive or cement can last severalhours. In an embodiment, the adherence can last up to one day. In anembodiment, the adherence can last up to two days or more. It will beappreciated that the adherence can last long enough to meet the user orpatient's needs.

The urinary catheter 400 includes a valve 440. The valve 400 can bedisposed within the urinary catheter 400 in whole or portion. The valve400 can be any type or design suitable and adaptable to use in theurinary catheter 400. The valve 400 can be opened and closed manually,electronically, remotely, or by any suitable means. Referring to FIG.5A, FIG. 5A schematically illustrates the valve 440 in a closing state,according to an embodiment. The valve 440 can include a spring 442, aplunger 443, a support 444, and a leaf 445. The valve 440 is normallyclosed. That is, the leaf 445 is normally in a closed position where theleaf 445 is in sealing contact with the support 444 to block the urineflow F from the bladder. A portion of the plunger 443 can extend underthe leaf 445 to provide additional support to maintain the leaf 445 atthe closed position while the urine pressure within the urinary catheter400 is increasing. In an embodiment, the leaf 445 is retained to thevalve 440 through a hinge 447, along which the leaf can be rotated tothe closed position from an open position.

Referring to FIG. 5B, FIG. 5B schematically illustrates the valve 440 ina closed state from a top view along the urine flow F, according to anembodiment. The leaf 445 is in the closed position, blocking the urineflow F. The hinge 447 can include hinge 447A and hinge 447B acting asrotation pivots for turning the leaf 445 to the closed or open position.

Referring to FIG. 5C. FIG. 5C schematically illustrates a valve in anopen state from a side view, according to an embodiment. The spring 442can be connected with the plunger 443, and the movement of the spring442 can cause the movement of the plunger 443. In an embodiment, whenthe spring 442 contracts, the plunger 443 retracts and no longersupports the leaf 445, which causes the leaf 445 to rotate to an openposition due to, for example, the urine pressure within the urinarycatheter 400. As such, the valve 440 is turned on, and the urine flowsthrough the valve 440.

FIG. 5D schematically illustrates a valve in an open state from a topview along the urine flow F, according to an embodiment. The openposition results as the leaf 445 rotates at or about 90 degrees relativeto its closed position along the hinge 447 A and B. The leaf 445 isabout parallel to the urine flow direction F at the open position.

After the user or patient voids, the leaf 445 can return back to theclosed position due to the pressure drop within the urinary catheter400. In an embodiment, when the spring 442 expands, the plunger 443 ispushed back under the leaf 445 for closing the valve 440.

Referring to FIGS. 5A and 5C, the valve 440 can be a battery-poweredvalve. In an embodiment, the urinary catheter 400 further includes abattery 441. When the urinary catheter 400 is powered on, the spring 442contracts, which causes the plunger 443 to retract to a retractedposition shown in FIG. 5C, which in turn causes the leaf 445 to be inthe open position due to the pressure of the flow F. As such, the valve440 is turned on, which permits urine flowing through the valve 440.

In an embodiment, the leaf 445 can automatically return to the closedposition when the urine pressure within the urinary catheter 400 dropsto a desired threshold after voiding. In an embodiment, the desiredthreshold after voiding is the pressure within the bladder after thepatient voids. The leaf 445's ability to automatically return to theclosed position at the desired threshold after voiding helps preventresidual urine in the bladder from leaking through the urinary catheter400.

In an embodiment, when the urinary catheter 400 is powered off, thespring 442 expands, which causes the plunger 443 to be pushed back toits original position, as shown in FIG. 5A. The plunger 443 supports theleaf 445 so that the leaf 445 can be maintained at the closed positionuntil the urinary catheter 400 is powered on.

In an embodiment, the urinary catheter 400 further includes a coil 446.In an embodiment, when the urinary catheter 400 is powered on, electriccurrent flows through the coil and generates an electromagnetic field,which causes the spring 442 to contract and, in turn, enables theplunger 443 to retract to open the valve 440. In an embodiment, when theurinary catheter 400 is powered off, the electric current stops flowingthrough the coil 446. The coil 446 no longer generates anelectromagnetic field, which causes the spring 442 to expand and, inturn, the plunger 443 to be pushed back to its original position toclose the valve 440.

In an embodiment, the valve 440 further includes a pressure sensor 448that can detect the urine pressure within the urinary catheter 400. Whenthe pressure reaches a desired voiding threshold, the pressure sensor448 automatically sends a signal to notify the user or patient to void.In an embodiment, the desired voiding threshold is the pressure within anormal person's bladder that causes an urge to void. In an embodiment,the sensor includes a speaker, and the signal is a sound such as, forexample, a beep sound or the like so that the patient knows the bladderpressure reaches a level that the bladder needs to be emptied. In anembodiment, the sensor includes a vibrator, and the signal is avibration.

Referring to FIG. 6 , FIG. 6 schematically illustrates using a sensorand a portable or wearable device to control the closing and opening ofthe valve 440. In an embodiment, the valve 440 further includes a signaltransmitter and receiver 615 and a controller 665. At 610, the sensor448 detects the urine pressure within the valve 440 and transmits anelectric signal encoding the detected pressure to the signal transmitterand receiver 615.

At 620, the signal transmitter and receiver 615 transmits the electricsignal encoding the detected pressure to a portable/wearable device 625.In an embodiment, the signal transmitter and receiver 615 transmits theelectric signal via a wire or cable. In an embodiment, the cable is aUSB cable or micro-USB cable, or the like. In an embodiment, the signaltransmitter and receiver 615 is a radio signal transmitter and receivercapable of communicating with the portable/wearable device 625wirelessly via Bluetooth, NFC, RFID, network, or the like. Examples ofthe network include, but are not limited to, for example, Wi-Fi,cellular, 2G, 3G, 4G, 5G, 6G, or any other suitable wireless network.The portable or wearable device 625 includes but not be limited to, forexample, a smartphone, smartwatch, tablet, or the like. In anembodiment, the sensor 448 communicates with the portable/wearabledevice 625 through an application installed in the device.

At 630, the portable/wearable device 625 receives the radio signaltransmitted from the signal transmitter and receiver 615. Theportable/wearable device 625 can include an application to determine ifthe detected pressure reaches the desired voiding threshold or thedesired threshold after voiding and then generate a notice such as, forexample, a sound, vibration, message, phone call, or a combinationthereof to notify a user to turn on or shut off the valve 440. The usercan be the patient or a caregiver of the patient.

At 640, the user turns on or shuts off the valve 440 through theapplication. In an embodiment, the application or sensor is configuredto automatically shut off the valve 440 when the urine pressure is belowthe desired threshold after voiding.

At 650, the portable device/wearable device 625 sends the user's commandto the signal transmitter and receiver for turning on or shutting offthe valve 440.

At 660, the signal transmitter and receiver sends the user's command tothe controller 625. At 670, the controller 625 turns on or off the powerof the valve 440 per the user's command.

In an embodiment, the urinary catheter 440 further includes a urinestorage bag or container that fluidly connects to the urine passage 105for receiving and storing urine exiting from the valve 440. It isappreciated that the urinary catheter 100 and the urethral plug 200 canalso include the urine storage bag or container for receiving andstoring urine exiting from the urine passage thereof.

In an embodiment, the urethral catheter and plug discussed above notonly prevent microbes from migrating into the bladder but also inhibitand/or kill microbes. In an embodiment, structures of the urinarycatheter or plug, including the urinary catheter 100, the urethral plug200, the urethral plug 300, and the urinary catheter 400 discussedabove, can independently include an antimicrobial material, for example,an antimicrobial polymer material. The antimicrobial material canprevent catheter-associated urinary tract infections (CAUTI). A varietyof antimicrobial materials may suitably be used. In an embodiment, asuitable antimicrobial material may include a N-halogenated amino acidor a derivative thereof. In an embodiment, a suitable antimicrobialmaterial may include an antibiotic. In an embodiment, a suitableantimicrobial material may comprise a polymeric composite comprising apolymer and an antimicrobial particle. In an embodiment, theantimicrobial particle may include one or more of (nano)silver, copper,and, keratin, and the like. In an embodiment, a suitable antimicrobialmaterial comprises a polymer material where an antimicrobial particle isembedded. In an embodiment, an antimicrobial particle may be coated ontothe polymer material. In an embodiment, the antimicrobial material iscoated on a surface of the portions or elements of the urinary catheteror plug. In an embodiment, the urinary catheter or plug can be coatedwith material(s) that can inhibit or prevent infection(s). In anembodiment, the material(s) can inhibit biofilm(s). In an embodiment,the material(s) include heparin. In an embodiment, the material(s)consist of heparin. Various methods can be employed to contact or coatthe surfaces of the urinary catheter or plug with an antimicrobialagent. For example, one method would be to soak the surfaces of theurinary catheter or plug with an antimicrobial-containing solution.

Referring to FIG. 7A, FIG. 7A schematically shows a side view ofplatform 720, according to an embodiment. The platform 720 can be anembodiment of the platform 120 and 220. The platform 720 is disposed onthe elongation body 101 of a urinary catheter 700 similar to the urinarycatheter 100, the urethral plug 200, and the urinary catheter 400. In anembodiment, the platform 720 can slide along the elongation body 101 toadjust its position. In an embodiment, a user can apply, spray, or paintan adhesive and/or cement onto the platform 120 or the elongation body101 and then adjust the platform 720 to a suitable position. When theadhesive and/or cement takes effect, the platform 720 is adhered to theelongation body 101. The platform 720 includes a holder 740 and asealing structure 760. In an embodiment, the holder 740 is connected orattached to the sealing structure 760. The sealing structure 760 adheresthe platform 720 onto the urethral mucous membrane and/or externalorifice. A user can grab the holder 740 to detach the platform 720 fromthe adhered mucous membrane and/or orifice when the user wants to removethe urinary catheter 700. In an embodiment, the holder 740 includes aridge 742 to facilitate taking off the urinary catheter 700.

Referring to FIG. 7B, FIG. 7B schematically shows a tilted view of theplatform 720, according to an embodiment. The sealing structure 760includes a first sealing structure 770, a support structure 765, and asecond sealing structure 780. The first sealing structure 770 includes afirst adhesive surface 773 for adhering the platform 720 onto theurethral mucous membrane and/or orifice. In an embodiment, the firstadhesive surface 773 contains an adhesive or cement. In an embodiment,the first adhesive surface 773 is covered by a cover 774, such as, forexample, a liner, when the platform 720 is manufactured. A user can takeor peel off the cover 774 to expose the first adhesive surface 773before or when the platform 720 is in place for use. In an embodiment,the first adhesive surface 773 is formed by applying, spraying, orpainting an adhesive or cement thereon before use.

Referring to FIG. 7C, FIG. 7C schematically shows an exploded view ofthe sealing structure 760, according to an embodiment. The supportstructure 765 can be disposed between the first sealing structure 770and the second sealing structure 780. In an embodiment, the supportstructure 765 is sandwiched between the first sealing structure 770 andthe second sealing structure 780. In an embodiment, the supportstructure 765 is connected or attached to the holder 740. In anembodiment, the support structure 765 and the holder 740 are a unitaryone-piece construction. In an embodiment, the support structure 765 ismolded to the holder 740.

The first sealing structure 770 can further includes a second adhesivesurface 775 that opposes the first adhesive surface 773 and faces thesupport structure 765. In an embodiment, the second adhesive surface 775is covered by a cover 776, such as, for example, a liner, when theplatform 720 is manufactured. A user can take or peel off the cover 774to expose the second adhesive surface 775 before or when the platform720 is in place for use. In an embodiment, the first sealing structure770 is a double-sided tape. In an embodiment, the second adhesivesurface 775 is formed by applying, spraying, or painting an adhesiveand/or cement thereon before use.

The second sealing structure 780 includes a first side 782 and a secondside 784. The first side 782 opposes the second side 784 and faces thesupport structure 765. The first side 782 is provided with an adhesiveand/or cement. In an embodiment, the first side 782 is covered by acover 783, such as, for example, a liner, when the platform 720 ismanufactured. A user can take or peel off the cover 783 to expose theadhesive and/or cement before or when the platform 720 is in place foruse. In an embodiment, the second sealing structure 780 is asingle-sided tape. In an embodiment, the adhesive or cement is applied,sprayed, or painted on the first side 782 before use.

The first adhesive surface 773 of the first sealing structure 770adheres to the urethral mucous membrane and/or orifice to seal theurethra. The second adhesive surface 775 of the first sealing structure770 adheres to one side of the support structure 765, and the first side782 of the second sealing structure 780 adheres to the other side of thesupport structure 765, forming a sandwich structure, in which thesupport structure 765 is sandwiched between the first sealing structure770 and the second sealing structure 780. The sandwich structure notonly seals the urethra but also attaches to the elongation body 101,allowing a user to detach the first sealing structure 770 from theadhered tissues by pulling the urinary catheter 700 or the holder 740.

The first sealing structure 770 can adhere to the support structure 765more strongly than to the urethral mucous membrane and/or orifice sothat a user to detach the first sealing structure 770 from the urethralmucous membrane and/or orifice by pulling the catheter 700 or the holder740. In an embodiment, the support structure 765 has a plurality ofpores 766 allowing adhesive and/or cement provided on the first side 782and the second adhesive surface 775 to pass through, which can enhancethe adherence of the first sealing structure 770 to the supportstructure 765. In an embodiment, the first sealing structure 770 and thesecond sealing structure 780 are larger than the support structure 765in area so that portions of the first sealing structure 770 and thesecond sealing structure 780 can stick together directly to enhance theadherence of the first sealing structure 770 onto the support structure765. In an embodiment, the first sealing structure 770 and the secondsealing structure 780 have a diameter larger than the support structure765.

In an embodiment, the first side 782 can include an acrylic adhesive orany other suitable adhesive/cement. In an embodiment, the first adhesivesurface 773 and/or the second adhesive surface 775 can include ahydrocolloid adhesive or any other suitable adhesive/cement.

The material, softness, and pliability of the sealing structure 760 aresimilar to those discussed above for the platform 120. In an embodiment,the material, softness, and pliability of the holder 740 are similar tothose discussed above for the attachment 203 and/or the distal portion180

The first sealing structure 770, the support structure 765, and thesecond sealing structure can be any suitable form or have any suitableshape, including but not limited to round, oval, rectangle, etc. In anembodiment, the first sealing structure 770, the support structure 765,and the second sealing structure have a disk shape. In an embodiment,the first sealing structure 770, the support structure 765, and thesecond sealing structure are deformable and can adopt a shape to matethe surface contour of the urethral membrane and/or orifice.

It is appreciated that the devices in this disclosure, including theurinary catheter 100, the urethral plug 200, the urethral plug 300, theurinary catheter 400, and the urinary catheter 700 can apply to bothmale and female patients with or without apparent modification. Suchmodification should be understood as being within the scope of thisdisclosure. It is also appreciated that the devices in this disclosurecan be used in preventing, reducing, and managing urinary tractinfections.

ASPECTS

Any one of aspects 1-23 is combinable to any one of aspects 24-28.

Aspect 1. A device for managing urinary incontinence of a patient inneed thereof, comprising one or more materials selected from the groupconsisting of a silicone material, a thermoplastic material, athermos-impression material, an adhesive, and a cement for sealing theurethra,

wherein the materials are non-tissue irritating, non-allergenicmaterials,

the adhesive or cement is capable of adhering the device to a urethramucous membrane or orifice and sealing the gaps therebetween.

Aspect 2. The device of aspect 1, wherein that the silicone material andthe thermoplastic material are capable of softening at a bodytemperature of the urethra to fit a contour of an inner surface of theurethra and/or a terminal end of the urethra and obtain a seal oradherence sufficient to prevent bacterial migration into the urethraand/or bladder.Aspect 3. The device of any one of aspects 1 and 2, wherein thethermoplastic material is a thermoplastic elastomer includes at leastone selected from the group consisting of styrenic block copolymers,thermoplastic olefin blends (TPO), thermoplastic polyurethanes (TPU),elastomeric alloys (TPV), thermoplastic copolyester (COPE), andpolyether block amides (PEBAX),

the adhesive or cement is selected from the group consisting of asilicone adhesive, a hydrocolloid adhesive, an acrylic adhesive, and acombination thereof,

and the thermo-impression material is selected from the group consistingof a polysiloxane material, a polyether material, and a combinationthereof.

Aspect 4. The device of any one of aspects 1-3, wherein thethermoplastic elastomer has hardness in a range of 10 to 40 on the Shore00 scale of hardness at body temperature.

Aspect 5. The device of any one of aspects 1-4, wherein thethermoplastic elastomer has a hardness in a range of 40 to 65 on theShore 00 scale of hardness at body temperature.

Aspect 6. The device of any one of aspects 1-5, wherein the devicefurther comprises an inner body, and the thermoplastic elastomer isprovided around the inner body.

Aspect 7. The device of aspect 6, wherein the inner body is anelastomer.

Aspect 8. The device of any one of aspects 1-5, wherein the devicefurther comprises an elongated body insertable into a urethra through anexternal opening of a urethra,

the thermoplastic elastomer constitutes a platform around the elongatedbody,

the adhesive is disposed on a first surface of the platform, and

the first surface contacts the mucous membranes of the urethra orurethra orifice.

Aspect 9. The device of aspect 8, wherein the platform is movableaxially along the elongated body, and the platform can be retained atdifferent positions of the elongated body.

Aspect 10. The device of aspect 9, wherein the device further comprisesa retainer for retaining the platform at different positions of theelongated body, and the platform is axially movable along the retainer.

Aspect 11. The device of aspect 9, wherein the platform contains asecond adhesive disposed at a second surface of the platform, where thesecond adhesive directly adheres the platform to the elongated body,

the second adhesive is releasable and reusable so that the platform iscapable of dislodging from the elongated body by force and re-adheringto a new position at the elongated body, and

the second adhesive is selected from the group consisting of siliconeadhesive, hydrocolloid adhesive, and acrylic adhesive.

Aspect 12. The device of aspect 11, wherein the second adhesive is asilicone adhesive or cement.

Aspect 13. The device of any one of aspects 8-12, wherein the elongatedbody includes a proximal portion and a distal portion opposing theproximal portion,

the device further comprises an inflatable balloon disposed at theproximal portion, and the inflatable balloon includes a thermoplasticelastomer and/or an adhesive capable of sealing an internal orifice ofthe urethra.

Aspect 14. The device of any one of aspects 8-13, wherein the elongatedbody includes a urine passage.

Aspect 15. The device of any one of aspects 13-14, wherein the proximalportion is firmer than the distal portion.

Aspect 16. The device of any one of aspects 13-15, wherein the proximalportion has a hardness in a range of 40 to 100 on the Shore A scale ofhardness at body temperature, and the distal portion has a hardness in arange of 0 to 40 on Shore A scale of hardness.Aspect 17. The device of any one of aspects 13-16, wherein the devicefurther includes an inflation tube and an inlet, and the inflation tubeis in fluid communication with the balloon.Aspect 18. The device of any one of aspects 1-17, wherein the devicefurther includes a urination controller for controlling urination.Aspect 19. The device of aspect 18, wherein the urination controllerincludes a plug or valve.Aspect 20. The device of aspect 19, wherein the valve is a palpitatabledischarge valve.Aspect 21. The device of aspect 19, wherein the valve comprises abattery, a coil, a spring, a plunger, and a leaf,

-   -   wherein the spring is connected with the plunger,    -   the coil generates an electromagnetic field when electric        current flows through the coil, which causes the spring to        contract and, in turn, causes the plunger to retract to turn on        the valve, and    -   when the electric current stops flowing through the coil, the        coil no longer generates an electromagnetic field, and the        spring expands, which in turn causes the plunger to extend to        close the valve.        Aspect 22, the device of aspect 21, wherein the valve further        comprises a sensor for detecting a urine pressure in the        urethra, and

when the urine pressure reaches a desired thresholds pressure, thesensor sends a signal to notify a patient to turn on the valve to void.

Aspect 23, the device of aspect 1-22, comprising a urine collection bagor container that fluidly connects with the urine passage for receivingand storing urine exited from the urine passage.

Aspect 24. A method for managing urinary incontinence, comprisinginserting the device of any one of aspects 1-23 through the externalorifice of urethra, wherein the platform is disposed within the urethraand seals the urethra.

Aspect 25. The method of aspect 24, wherein inserting the deviceincludes inserting the balloon inside a bladder.

Aspect 26. The method of aspect 25, further comprising inflating theballoon.

Aspect 27. The method of aspect 26, further comprising pulling theballoon so that the balloon is in sealing contact with a neck of thebladder.

Aspect 28. The method of aspect 27, wherein the platform seals theurethra, and the balloon seals the internal orifice of the urethra.

I claim:
 1. A device for managing urinary incontinence of a patient inneed thereof, comprising: an elongated body insertable into a urethrathrough an external opening of the urethra, a platform disposed aroundthe elongated body, a urine passage disposed within the elongated body,an inflatable balloon, and a valve to control voiding through the urinepassage, wherein the platform comprises a first sealing structure, asupport structure, and a second sealing structure, the support structureis fixable to the elongated body, and the first sealing structureincludes a first adhesive surface and a second adhesive surface opposingthe first adhesive surface, wherein the first adhesive surface containsa first adhesive or cement that is capable of adhering the platform to aurethral mucous membrane or orifice, and the second adhesive surfacefaces the support structure and contains a second adhesive or cementthat is capable of adhering the first sealing structure to the supportstructure.
 2. The device of claim 1, wherein the platform furthercomprises a silicone, a thermo-impression material, or thermoplasticmaterial capable of softening at a body temperature of the urethra sothat the silicone, thermo-impression material, or thermoplastic materialis adapted to a shape fitting a contour of an inner surface of theurethra and/or a terminal end of the urethra.
 3. The device of claim 2,wherein the thermoplastic material is a thermoplastic elastomer thatincludes at least one selected from the group consisting of styrenicblock copolymers, thermoplastic olefin blends (TPO), thermoplasticpolyurethanes (TPU), elastomeric alloys (TPV), thermoplastic copolyester(COPE), and polyether block amides (PEBAX), and the thermo-impressionmaterial is a polysiloxane material or a polyether material or acombination thereof.
 4. The device of claim 2, wherein the silicone is asilicone rubber or a liquid silicone rubber.
 5. The device of claim 1,wherein the support structure comprises an adhesive surface containingan adhesive or cement that is capable of adhering the platform directlyto the elongated body, and the adhesive or cement is releasable andreusable so that the platform is movable axially along the elongatedbody and retained at different positions of the elongated body.
 6. Thedevice of claim 1, wherein the first adhesive surface is covered with arelease cover.
 7. The device of claim 1, wherein each of the first andthe second adhesive or cement are independently selected from the groupconsisting of a silicone adhesive or cement, a hydrocolloid adhesive orcement, an acrylic adhesive or cement, and a combination thereof.
 8. Thedevice of claim 1, wherein the inflatable balloon includes athermoplastic elastomer capable of softening at a body temperature forsealing an internal urethral orifice.
 9. The device of claim 1, whereinthe inflatable balloon includes an adhesive capable of sealing aninternal orifice of the urethra, and the adhesive is one or moreselected from the group consisting of silicone adhesive, a hydrocolloidadhesive, and an acrylic adhesive.
 10. The device of claim 1, furthercomprising a sensor to detect a urine pressure within the valve, thesensor is configured to send a signal to notify a user to turn on orshut off the valve when the urine pressure reaches a desired thresholdpressure.
 11. The device of claim 10, wherein the sensor furtherincludes a speaker or vibrator, and the signal is respectively a soundor a vibration.
 12. The device of claim 10, wherein the valve furthercomprises a signal transmitter and receiver and a controller, the signaltransmitter and receiver receives an electric signal encoding thedetected urine pressure and transmits the electric signal wirelessly toa portable or wearable device.
 13. The device of claim 12, wherein theportable or wearable device is a smartphone, a smartwatch, or a tablet.14. The device of claim 1, wherein the valve comprising: a battery; acoil; a spring; a plunger; and a leaf, wherein the spring is connectedwith the plunger, and the plunger is connected with the leaf, the coilgenerates an electromagnetic field when electric current flows throughthe coil, which causes the spring to contract and in turn causes theplunger to retract to turn on the valve, and when the electric currentstops flowing through the coil, the coil no longer generates theelectromagnetic field, and the spring expands, which in turn causes theplunger to extend to close the valve.
 15. The device of claim 1, whereinthe second sealing structure includes a first side and a second sideopposing the first side, the first side faces the support structure andcontains a third adhesive or cement that is capable of adhering thesecond sealing structure to the support structure.
 16. The device ofclaim 15, wherein the first adhesive surface, the second adhesivesurface, and the first side are covered with a release cover.
 17. Thedevice of claim 1, wherein the first sealing structure adheres to thesupport structure more strongly than to the urethral mucous membrane ororifice.
 18. The device of claim 1, wherein the first sealing structureand the second sealing structure have a size larger than the supportstructure so that a portion of the first and second sealing structureadhere to each other.
 19. The device of claim 1, wherein the supportstructure comprises a plurality of pores.
 20. A method for managingurinary incontinence of a patient, comprising: inserting the device ofclaim 1 through the external orifice of the urethra of a patient in needthereof, inflating the inflatable balloon, the inflatable balloonincludes a thermoplastic elastomer and/or a silicone adhesive, pullingthe inflatable balloon so that the thermoplastic elastomer and/oradhesive is in sealing contact with a neck of the bladder, and adjustingthe platform to a suitable position at the elongated body for sealingthe urethra, wherein the platform seals the urethra, and the balloonseals the internal orifice of the urethra.